FDA - Regulated Products
WPP #: XVI-7
Control of Investigational Drugs, Devices, and Biologics
4-15-08; 2-28-10; 11-1-2015
Investigators conducting studies in which investigational products will be used must ensure adequate control of the drug, device, or biologic. The VCU IRB requires the Investigational Drug Services Pharmacy be used for study drug management when studies involve the use of investigational drugs or biologics. When studies involve the use of investigational devices, the VCU IRB requires that the research plan submitted to the IRB include a description of how the investigational device(s) will be stored and controlled.
- Investigational Drugs and Biologics:
The VCU IRB requires use of the Investigational Drug Services (IDS) Pharmacy for studies which utilize investigational drugs and/or biologics, regardless of whether the study involves inpatient or outpatient visits. There may be minor exceptions to this requirement if utilization of the IDS is not logistically feasible, such as at off-site locations where VCU Medical Center pharmacy services are unavailable.
If an investigator needs to maintain control of outpatient study drugs for a particular protocol, a Drug Management Plan must be submitted online to the IDS and provided to the IRB. The IRB will not approve a protocol with a Drug Management Plan without verification that the IDS has approved the plan.
If requesting an exemption from the IDS requirement, the investigator must submit a completed management plan for non-IDS investigational drugs and biologics to the IDS. The management plan application is located on the IDS website at: www.investigationaldrugs.vcu.edu and should be completed and submitted on-line. Provide a copy of the IDS management plan approval to the VCU IRB or external IRB with the IRB application.
Submitting a management plan to the IDS is not required if either:
- The following three criteria are all met:
- the drug used in the study is FDA-approved, considered standard of care, and is a patient charge item,
- off-label use of such a drug is not being studied, AND
- there is no protocol requirement for specific management of the drug.
- Investigational drug product is being managed by an accredited cellular therapeutics lab or nuclear pharmacy.
If an off-site drug management plan is approved, the IDS monitors compliance with the management plan as a quality improvement initiative. IDS findings of noncompliance and related risk to subjects should be forwarded to the IRB by the investigator as a report for ‘Unanticipated Problems Involving Risks to Subjects or Others.”
- The following three criteria are all met:
- Investigational Devices and Humanitarian Use Devices (HUDs):
For VCU IRB submission, the investigator must describe a plan for the control of investigational devices and HUDs within the RAMS-IRB submission.
The questions in the submission form guide the investigator in describing control of the investigational device or HUD and serve as a guide for the VCU IRB reviewer. The IRB reviewer is to ascertain that the elements requested in the submission (pertaining to the plan for the control of investigational device or HUD) have been addressed.
- Control of Investigational Products
Safe and effective control and handling of investigational drug/biologic is comprehensively described in the ICH Guidance for Good Clinical Practice. Selected relevant criteria are summarized as follows:
- The investigational article is used only in accordance with the VCU IRB-approved protocol.
- Administer the investigational article only to participants under the investigator’s direct personal supervision or under the supervision of a sub-investigator directly responsible to the investigator.
- The investigational article is supplied only to person authorized to receive it.
- Maintain records of the disposition of the investigational article, including dates of dispensing, quantity currently maintained for dispensing, and amount of the investigational product dispensed to participants.
- Any unused supplies of the investigational drug/biologic to the study sponsor, or otherwise provide for disposition of the unused supplies as directed by the sponsor if the investigation is terminated or suspended.
- 6. Precautions are taken to prevent theft or diversion of the substance into illegal channels of distribution especially if the investigational drug is subject to the Controlled Substances Act. Precautions include: storage of the investigational drug in a securely locked, substantially constructed cabinet or other securely locked, substantially constructed enclosure to which access is limited.
ICH E6 Good Clinical Practice
VCU Clinical Research Standard Operating Procedures
VCU Medical Center Investigational Drug Service
VCUHS Policies Related to Clinical Research
VCU IRB WPP VII-6; Reporting to the IRB and the Required Reporting of Unanticipated Problems Involving Risk or Harm to Subjects or Others